ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
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| Active as of 2024-11-26 |
{
"resourceType" : "Requirements",
"id" : "EHRSFMR2.1-CPS.2.5",
"meta" : {
"profile" : [
🔗 "http://hl7.org/ehrs/StructureDefinition/FMFunction"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <span id=\"description\"><b>Statement <a href=\"https://hl7.org/fhir/versions.html#std-process\" title=\"Normative Content\" class=\"normative-flag\">N</a>:</b> <div><p>Capture and explicitly label patient-originated data, link the data source with the data, and support provider authentication for inclusion in patient health record.</p>\n</div></span>\n\n \n <span id=\"purpose\"><b>Description <a href=\"https://hl7.org/fhir/versions.html#std-process\" title=\"Informative Content\" class=\"informative-flag\">I</a>:</b> <div><p>It is critically important to be able to distinguish clinically authored and authenticated data from patient-originated data that is either provided by the patient for inclusion in the EHR or entered directly into the EHR by the patient from clinically authenticated data. Patients may provide data for entry into the health record or be given a mechanism for entering this data directly. Patient-originated data intended for use by providers will be available for their use.</p>\n<p>Data about the patient may be appropriately provided by:</p>\n<ul>\n<li>\n<p>the patient;</p>\n</li>\n<li>\n<p>a surrogate (e.g., parent, spouse, guardian);</p>\n</li>\n<li>\n<p>an informant (e.g., teacher, lawyer, case worker); or</p>\n</li>\n<li>\n<p>devices (e.g., blood pressure/sugar monitors).</p>\n</li>\n</ul>\n<p>An electronic health record may provide the ability for direct data entry by any of these. Patient-originated data may also be captured by devices and transmitted for inclusion into the electronic health record.</p>\n<p>Data entered by any of these must be stored with source information. A provider must authenticate patient-originated data included in the patient's legal health record. A provider must be able to indicate they have verified the accuracy of patient-originated data (when appropriate and when a verification source is available) for inclusion in the patient record.</p>\n<p>Such verification does not have to occur at each individual data field and can be at a higher level of the data.</p>\n</div></span>\n \n\n \n\n \n <span id=\"requirements\"><b>Criteria <a href=\"https://hl7.org/fhir/versions.html#std-process\" title=\"Normative Content\" class=\"normative-flag\">N</a>:</b></span>\n \n <table id=\"statements\" class=\"grid dict\">\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.2.5#01</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHALL</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHALL capture the source of clinical data provided on behalf of the patient and tag the data accordingly.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.2.5#02</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHALL</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHALL provide the ability for an authorized user (e.g., clinician) to tag as accurate and verified patient-originated data (when appropriate and when a verification source is available) for inclusion in the patient record (e.g., patient-orginated allergy report is verified by clinician so that it may appear in the allergy list).</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.2.5#03</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHALL</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHALL capture patient-sourced data distinctly from provider-sourced data (i.e. ensure that provider sourced data is not modified by patient-sourced data).</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.2.5#04</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHALL</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHALL capture both structured and unstructured data as defined in [[RI.1.2.1]] (Manage Record Entries).</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.2.5#05</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD provide the ability to transmit notifications to consumer health solutions, such as Personal Health Records (PHRs) or home monitoring devices.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n <tr>\n <td style=\"padding-left: 4px;\">\n \n <span>CPS.2.5#06</span>\n \n </td>\n <td style=\"padding-left: 4px;\">\n \n \n \n <span>SHOULD</span>\n \n </td>\n <td style=\"padding-left: 4px;\" class=\"requirement\">\n \n <span><div><p>The system SHOULD provide the ability to receive notifications from consumer health solutions, such as PHRs or home monitoring devices.</p>\n</div></span>\n \n \n </td>\n </tr>\n \n </table>\n</div>"
},
"url" : "http://hl7.org/ehrs/Requirements/EHRSFMR2.1-CPS.2.5",
"version" : "2.1.0",
"name" : "CPS_2_5_Support_patient_originated_Data",
"title" : "CPS.2.5 Support patient-originated Data (Function)",
"status" : "active",
"date" : "2024-11-26T16:30:50+00:00",
"publisher" : "EHR WG",
"contact" : [
{
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/ehr"
}
]
}
],
"description" : "Capture and explicitly label patient-originated data, link the data source with the data, and support provider authentication for inclusion in patient health record.",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
]
}
],
"purpose" : "It is critically important to be able to distinguish clinically authored and authenticated data from patient-originated data that is either provided by the patient for inclusion in the EHR or entered directly into the EHR by the patient from clinically authenticated data. Patients may provide data for entry into the health record or be given a mechanism for entering this data directly. Patient-originated data intended for use by providers will be available for their use.\n\nData about the patient may be appropriately provided by: \n\n- the patient;\n\n- a surrogate (e.g., parent, spouse, guardian); \n\n- an informant (e.g., teacher, lawyer, case worker); or\n\n- devices (e.g., blood pressure/sugar monitors).\n\nAn electronic health record may provide the ability for direct data entry by any of these. Patient-originated data may also be captured by devices and transmitted for inclusion into the electronic health record.\n\nData entered by any of these must be stored with source information. A provider must authenticate patient-originated data included in the patient's legal health record. A provider must be able to indicate they have verified the accuracy of patient-originated data (when appropriate and when a verification source is available) for inclusion in the patient record.\n\nSuch verification does not have to occur at each individual data field and can be at a higher level of the data.",
"statement" : [
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.2.5-01",
"label" : "CPS.2.5#01",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture the source of clinical data provided on behalf of the patient and tag the data accordingly.",
"derivedFrom" : "EHR-S_FM_R1.1 DC.1.1.3.2#3"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.2.5-02",
"label" : "CPS.2.5#02",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL provide the ability for an authorized user (e.g., clinician) to tag as accurate and verified patient-originated data (when appropriate and when a verification source is available) for inclusion in the patient record (e.g., patient-orginated allergy report is verified by clinician so that it may appear in the allergy list).",
"derivedFrom" : "EHR-S_FM_R1.1 DC.1.1.3.2#5"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.2.5-03",
"label" : "CPS.2.5#03",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture patient-sourced data distinctly from provider-sourced data (i.e. ensure that provider sourced data is not modified by patient-sourced data).",
"derivedFrom" : "EHR-S_FM_R1.1 DC.1.1.3.2#9"
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.2.5-04",
"label" : "CPS.2.5#04",
"conformance" : [
"SHALL"
],
"conditionality" : false,
"requirement" : "The system SHALL capture both structured and unstructured data as defined in [[RI.1.2.1]] (Manage Record Entries)."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.2.5-05",
"label" : "CPS.2.5#05",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD provide the ability to transmit notifications to consumer health solutions, such as Personal Health Records (PHRs) or home monitoring devices."
},
{
"extension" : [
{
"url" : "http://hl7.org/ehrs/StructureDefinition/requirements-dependent",
"valueBoolean" : false
}
],
"key" : "EHRSFMR2.1-CPS.2.5-06",
"label" : "CPS.2.5#06",
"conformance" : [
"SHOULD"
],
"conditionality" : false,
"requirement" : "The system SHOULD provide the ability to receive notifications from consumer health solutions, such as PHRs or home monitoring devices."
}
]
}